Comparison of Microwave Ablation With Breast Conserving Surgery for Breast Tumor

Not Applicable

• Conditions: Breast Tumor; Breast Conserving Surgery; Microwave Ablation
• Interventions: Procedure: microwave ablation; Procedure: breast conserving surgery

• Registration Number: NCT04626986
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

The investigators will perform this study to prospectively compare the clinical outcome after percutaneous microwave ablation(MWA) and breast conserving surgery of benign and malignant breast lesion under ultrasound (US) guidance.

Detailed Description

A total of more than 300 patients diagnosed with breast tumor in multiple centers will be recruited in this study and underwent US-guided percutaneous MWA and breast conserving surgery treatment. Information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. Ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be compared and analyzed.

Study Timeline

• Study Start: 2020-09-18
• Study First Submitted: 2020-09-27
• Study First Submitted QC: 2020-11-08
• Study First Posted: 2020-11-13
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-26
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. women,
2. with invasive ductal carcinoma of the breast according to core-needle
3. tumor measuring 50mm or smaller, no axillary lymph node metastasis or Ipsilateral grade I and II axillary lymph node metastasis, movable(pT0-2N0-1M0 )
4. located at least 10 mm from the skin surface and chest wall.

Exclusion Criteria

1. men
2. women who were pregnant or breastfeeding
3. radiologic suspicion of multifocality or extensive intraductal carcinoma
4. histologic diagnosis of lobular carcinoma
5. neoadjuvant therapy
6. previous surgery or radiation therapy of the ipsilateral breast.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
microwave ablation	microwave ablation	Microwave ablation（MWA）refers to all electromagnetic methods of inducing tumor destruction by using devices with frequencies greater than or equal to 900MHz. The rotation of dipole molecules accounts for most of the heat generated during MWA. Water molecules as dipoles attempt to continuously reorient at the same rate in microwave's oscillating electric field. As a result of microwave transmission, the water molecules flip back and forth billions of times a second. The vigorous movement of water molecules produce friction and heat, thus inducing cellular death via coagulation necrosis. The microwave unit (KY-2000, Kangyou Medical, Nanjing, China) is capable of producing 100 Watts of power at 2450 MHz.The needle antenna has a diameter of 1.6 mm (16G) and a length of 10 cm. The active tip length is 3mm and 5mm.
breast conserving surgery	breast conserving surgery	Breast-conserving surgery refers to the removal of the primary tumor and adjacent breast tissue, supplemented by postoperative radiotherapy.Its principle is to remove the primary tumor completely while meet patient's cosmetic satisfaction.The combined treatment of early breast cancer with radiotherapy and chemotherapy is the same as radical surgery or modified radical surgery in terms of local and regional control rate and long-term survival rate. Breast conserving surgery and postoperative comprehensive treatment have become one of the main methods for the treatment of early breast cancer.

Primary Outcome Measures

Name	Time	Method
overall survival：Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)	5 years	Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
cosmetic satisfaction：Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）	3 years	Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）

Secondary Outcome Measures

Name	Time	Method
local tumor progress：Defined as the proportion of patients with active tumor at the edge of the treatment ：Defined as the proportion of patients with active tumor at the edge of the treatment	5 years	Defined as the proportion of patients with active tumor at the edge of the treatment area during follow-up after the tumor was completely treated
metastasis：Defined as the proportion of cases with metastasis from the beginning of the study to the end of the study or the death of the patient	5 years	Defined as the proportion of cases with metastasis from the beginning of the study to the end of the study or the death of the patient
complication：Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient	5 years	Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China